{"id":105322,"date":"2019-03-20T00:00:50","date_gmt":"2019-05-17T09:03:17","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/105322\/"},"modified":"2019-05-17T17:03:19","modified_gmt":"2019-05-17T09:03:19","slug":"2a4a2df36c","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/105322\/","title":{"rendered":"\u751f\u7269\u5236\u54c1\uff08\u6765\u6e90CHO\u8868\u8fbe\u4f53\u7cfb\uff09\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a"},"content":{"rendered":"
\n


<\/span><\/p>\n

\u6765\u6e90\u4e8eCHO\u8868\u8fbe\u7cfb\u7684\u751f\u7269\u6280\u672f\u4ea7\u54c1\u7684\u5177\u6709\u5b58\u5728\u75c5\u6bd2\u6c61\u67d3\u7684\u5371\u9669\u6027\uff0c\u8fd9\u79cd\u6c61\u67d3\u4f1a\u5728\u4e34\u5e8a\u4e2d\u5bfc\u81f4\u4e25\u91cd\u540e\u679c\uff0c\u6c61\u67d3\u53ef\u80fd\u6765\u6e90\u4e8e\u539f\u7ec6\u80de\u7cfb\u672c\u8eab\uff0c\u4e5f\u53ef\u80fd\u6765\u81ea\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5076\u7136\u5e26\u5165\u7684\u5916\u6e90\u75c5\u6bd2\uff0c\u4e3a\u4e86\u4fdd\u8bc1\u751f\u7269\u6280\u672f\u5236\u54c1\u7684\u5b89\u5168\uff0c\u9700\u8981\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5bf9\u75c5\u6bd2\u8fdb\u884c\u6d88\u9664\u548c\u706d\u6d3b\u4ee5\u964d\u4f4e\u6bcf\u5242\u91cf\u4e2d\u7684\u75c5\u6bd2\u6837\u9897\u7c92\u542b\u91cf\u81f3\u4e00\u5b9a\u6807\u51c6\u3002<\/span><\/p>\n

\n
\n
1.\u75c5\u6bd2\u6d88\u9664\u65b9\u6cd5<\/section>\n<\/section>\n<\/section>\n

\u5305\u62ec\u819c\u8fc7\u6ee4\u548c\u67f1\u5c42\u6790\u6cd5\u7b49\uff0c\u524d\u8005\u901a\u8fc7\u5b54\u5f84\u5927\u5c0f\u62e6\u622a\u75c5\u6bd2\uff0c\u5bf9\u6d88\u9664\u503e\u5411\u4e8e\u805a\u96c6\u7684\u75c5\u6bd2\u6709\u6548\uff1b\u540e\u8005\u6839\u636e\u75c5\u6bd2\u548c\u76ee\u6807\u86cb\u767d\u5728\u586b\u6599\u4e2d\u7684\u4e0d\u540c\u7ed3\u5408\u6216\u6d41\u7a7f\u65b9\u5f0f\uff0c\u4ece\u800c\u6d88\u9664\u86cb\u767d\u6eb6\u6db2\u4e2d\u7684\u75c5\u6bd2\u3002<\/span><\/p>\n

1.1 \u819c\u8fc7\u6ee4<\/span><\/strong>
<\/p>\n

\u53ef\u5206\u4e3a\u76f4\u6d41\u8fc7\u6ee4\u6280\u672f\u548c\u5207\u5411\u6d41\u8fc7\u6ee4\u6280\u672f\uff0c\u524d\u8005\u901a\u8fc7\u6df1\u5ea6\u5b54\u5f84\u62e6\u622a\u4f7f\u86cb\u767d\u5206\u5b50\u4e0e\u75c5\u6bd2\u9897\u7c92\u5f97\u5230\u6709\u6548\u5206\u79bb\uff0c\u5982\u56fe 1\u6240\u793a\uff1b\u540e\u8005\u901a\u8fc7\u8868\u9762\u5b54\u5f84\u62e6\u622a\u4f7f\u86cb\u767d\u5206\u5b50\u4e0e\u75c5\u6bd2\u9897\u7c92\u5f97\u5230\u6709\u6548\u62e6\u622a\uff0c\u5982\u56fe 2\u6240\u793a\u3002\u4f46\u819c\u8fc7\u6ee4\u53ea\u5bf9\u6ee4\u819c\u7684\u5b54\u5f84\u6bd4\u75c5\u6bd2\u6709\u6548\u76f4\u5f84\u5c0f\u624d\u80fd\u6709\u6548\u6d88\u9664\u75c5\u6bd2\uff0c\u4e00\u822c\u6765\u8bf4\u4e0d\u80fd\u5355\u72ec\u4f7f\u7528\uff0c\u9700\u8981\u4e0e\u5176\u4ed6\u65b9\u6cd5\u8054\u5408\u4f7f\u7528\u3002<\/span><\/p>\n

\"\u751f\u7269\u5236\u54c1\uff08\u6765\u6e90CHO\u8868\u8fbe\u4f53\u7cfb\uff09\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\"<\/p>\n

\u56fe1 \u76f4\u6d41\u8fc7\u6ee4\u6a21\u5f0f<\/span><\/p>\n


<\/p>\n

\"\u751f\u7269\u5236\u54c1\uff08\u6765\u6e90CHO\u8868\u8fbe\u4f53\u7cfb\uff09\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\"<\/p>\n

\u56fe2 \u5207\u5411\u6d41\u8fc7\u6ee4\u6a21\u5f0f<\/span><\/p>\n

1.2 \u67f1\u5c42\u6790\u6cd5<\/span><\/strong>
<\/p>\n

\u67f1\u5c42\u6790\u6cd5\u6839\u636e\u86cb\u767d\u8d28\u7684\u7406\u5316\u6027\u8d28\u7684\u4e0d\u540c\u8fdb\u884c\u86cb\u767d\u5206\u79bb\u7eaf\u5316\uff0c\u4ece\u800c\u8fbe\u5230\u5206\u79bb\u6742\u86cb\u767d\u53ca\u6d88\u9664\u75c5\u6bd2\u7b49\u6c61\u67d3\u7269\u7684\u95ee\u9898\uff0c\u67f1\u5c42\u6790\u6cd5\u5305\u62ec\u4eb2\u548c\u5c42\u6790\u3001\u79bb\u5b50\u4ea4\u6362\u3001\u53cd\u76f8\u5c42\u6790\u7b49\u3002<\/span><\/p>\n

\n
\n
2.\u75c5\u6bd2\u706d\u6d3b\u65b9\u6cd5<\/section>\n<\/section>\n<\/section>\n

\u53ea\u6709\u80fd\u591f\u90e8\u5206\u7834\u574f\u75c5\u6bd2\u7ed3\u6784\u6216\u6d3b\u6027\uff0c\u5e76\u7ef4\u6301\u751f\u7269\u6280\u672f\u836f\u7269\u7406\u5316\u6027\u8d28\u53ca\u751f\u7269\u5b66\u6d3b\u6027\u7684\u65b9\u6cd5\u624d\u662f\u6700\u7406\u60f3\u7684\u65b9\u6cd5\uff0c\u4f8b\u5982\u6709\u673a\u6eb6\u5242\/\u53bb\u6c61\u5242\uff08S\/D\uff09\u5904\u7406\u706d\u6d3b\u75c5\u6bd2\u3001\u4f4epH\u5b75\u80b2\u6cd5\u706d\u6d3b\u75c5\u6bd2\uff0c<\/span><\/p>\n

2.1 \u6709\u673a\u6eb6\u5242\u3001\u53bb\u6c61\u5242\uff08S\/D\uff09\u5904\u7406\u706d\u6d3b\u75c5\u6bd2<\/span><\/strong>
<\/p>\n

\u6709\u673a\u6eb6\u5242\u5982\u78f7\u9178\u4e09\u4e01\u916f\uff08TnBP\uff09\u548c\u975e\u79bb\u5b50\u5316\u7684\u53bb\u6c61\u5242\u5982TritonX-100\u6216\u5410\u6e2980\u7ed3\u5408\u53ef\u4ee5\u706d\u6d3b\u8102\u5305\u819c\u75c5\u6bd2\uff0c\u4f46\u5bf9\u975e\u8102\u5305\u819c\u75c5\u6bd2\u65e0\u6548\uff0cS\/D\u5904\u7406\u524d\u9700\u5148\u75281\u00b5m\u6216\u66f4\u5c0f\u5b54\u5f84\u7684\u6ee4\u5668\u53bb\u9664\u86cb\u767d\u6eb6\u6db2\u53ef\u80fd\u5b58\u5728\u7684\u9897\u7c92\uff08\u9897\u7c92\u53ef\u80fd\u85cf\u533f\u75c5\u6bd2\u4ece\u800c\u5f71\u54cd\u75c5\u6bd2\u706d\u6d3b\u6548\u679c\uff09\uff0c\u52a0\u5165S\/D\u540e\u9700\u786e\u4fdd\u662f\u5747\u4e00\u7684\u6df7\u5408\u7269\uff0c\u706d\u6d3b\u75c5\u6bd2\u5168\u8fc7\u7a0b\u5e94\u5c06\u6e29\u5ea6\u63a7\u5236\u5728\u89c4\u5b9a\u7684\u8303\u56f4\u5185\u3002\u5982\u679c\u52a0\u5165S\/D\u540e\u7acb\u523b\u8fc7\u6ee4\uff0c\u5219\u9700\u68c0\u6d4b\u8fc7\u6ee4\u540eS\/D\u7684\u6d53\u5ea6\u662f\u5426\u53d1\u751f\u53d8\u5316\uff0c\u5982\u6709\u53d8\u5316\u5e94\u8fdb\u884c\u8c03\u6574\u3002<\/span><\/p>\n

2.2 \u4f4epH\t\t\u5b75\u80b2\u6cd5\u706d\u6d3b<\/span><\/strong>
<\/p>\n

\u5f53\u4f7f\u7528\u4f4epH\u6761\u4ef6\u706d\u6d3b\u75c5\u6bd2\u65f6\uff0c\u706d\u6d3b\u6761\u4ef6\u5982pH\u3001\u5b75\u80b2\u65f6\u95f4\u3001\u6e29\u5ea6\u3001\u86cb\u767d\u8d28\u6d53\u5ea6\u3001\u76ee\u6807\u86cb\u767d\u4e2d\u7684\u75c5\u6bd2\u5206\u6563\u5f62\u5f0f\u7b49\u5747\u4f1a\u5f71\u54cd\u75c5\u6bd2\u706d\u6d3b\u6548\u679c\u3002<\/span><\/p>\n

\n
\n
3.\u75c5\u6bd2\u7c7b\u578b<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\u867d\u7136\u76ee\u524d\u4ee5\u9006\u8f6c\u5f55\u75c5\u6bd2\u7684\u6e05\u9664\u80fd\u529b\u4f5c\u4e3a\u6297\u4f53\u6216\u8005\u878d\u5408\u86cb\u767d\u7684\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u6307\u6807\uff0c\u53ea\u6709\u8fbe\u5230\u6307\u6807\uff0c\u65b9\u80fd\u8fdb\u5165\u4e00\u671f\u4e34\u5e8a\u5b9e\u9a8c\uff08FDA,1997\uff09\uff0c\u5e76\u4e14\u6bcf\u79cd\u75c5\u6bd2\u5728\u65e9\u671f\u548c\u540e\u671f\u9664\u75c5\u6bd2\u9a8c\u8bc1\u65f6\u7684\u4f7f\u7528\u9891\u7387\u4e0d\u540c\uff0c\u5728IND\u9636\u6bb5\uff0c\u9006\u8f6c\u5f55\u75c5\u6bd2\u3001\u7ec6\u5c0f\u75c5\u6bd2\u548c\u75b1\u75b9\u75c5\u6bd2\u5904\u4e8e\u4e3b\u5bfc\u5730\u4f4d\u3002\u4f46\u5728NDA\u548cBLA\u9636\u6bb5\uff0c\u4f1a\u4f7f\u75283-5\u79cd\u6a21\u578b\u75c5\u6bd2\uff0c\u4f7f\u7528\u547c\u80a0\u5b64\u3001\u5c0f\u6838\u7cd6\u6838\u9178\u75c5\u6bd2\u3001\u591a\u7624\u75c5\u6bd2\u7b49\u5176\u4ed6\u79cd\u7c7b\u75c5\u6bd2\u7684\u6bd4\u4f8b\u4f1a\u589e\u52a0\u3002<\/span><\/p>\n

\u5bf9\u4e8e\u8868 1\u4e2d\u6240\u542b\u56db\u79cd\u75c5\u6bd2\u7684\u6027\u8d28\u5728\u4e0d\u540c\u7684\u4e66\u4e2d\u5c55\u793a\u7684pI\u6216\u5927\u5c0f\u4f1a\u6709\u5dee\u5f02\uff0c\u4f46\u57fa\u672c\u4e00\u81f4\u3002\u5305\u819c\u75c5\u6bd2\u8868\u9762\u4e3a\u91cd\u590d\u7684\u86cb\u767d\u8d28\u548c\u7cd6\u86cb\u767d\uff0c\u4e3b\u8981\u7531\u5bf9\u79f0\u7684\u4e8c\u5341\u9762\u4f53\u58f3\u7ec4\u6210\uff0c\u7531\u4e8e\u7ed3\u6784\u5355\u4e00\uff0c\u6240\u4ee5\u8fd9\u4e9b\u5305\u819c\u75c5\u6bd2\u5177\u6709\u7c7b\u4f3c\u7684\u884c\u4e3a\u7279\u70b9\uff0c\u4f46\u662f\u4e0d\u592a\u786e\u5b9a\u4f53\u79ef\u3001\u786c\u5ea6\u4ee5\u53ca\u5bf9\u79f0\u6027\u7684\u6539\u53d8\u4f1a\u4e0d\u4f1a\u5f71\u54cd\u4e0d\u540c\u5305\u819c\u75c5\u6bd2\u7684\u6027\u8d28\u3002<\/span><\/p>\n

\u88681 \u5e38\u7528\u75c5\u6bd2\u6027\u8d28<\/span><\/p>\n\n\n\n\n\n\n\n
\n

\u75c5\u6bd2<\/strong><\/span><\/p>\n<\/td>\n

\n

\u7c7b\u578b<\/strong><\/span><\/p>\n<\/td>\n

\n

\u6027\u8d28<\/strong><\/span><\/p>\n<\/td>\n

\n

pI<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

X-MuLV<\/span><\/p>\n<\/td>\n

\n

\u9006\u8f6c\u5f55\u75c5\u6bd2<\/span><\/p>\n<\/td>\n

\n

\u5305\u819c\uff0cssRNA\uff0c80-120\t\t\tnm<\/span><\/p>\n<\/td>\n

\n

6.0-6.7<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

MVM<\/span><\/p>\n<\/td>\n

\n

\u7ec6\u5c0f\u75c5\u6bd2<\/span><\/p>\n<\/td>\n

\n

\u65e0\u5305\u819c\uff0cssDNA\uff0c18-26\t\t\tnm<\/span><\/p>\n<\/td>\n

\n

5.0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

PRV<\/span><\/p>\n<\/td>\n

\n

\u4f2a\u72c2\u72ac\u75c5\u6bd2<\/span><\/p>\n<\/td>\n

\n

\u5305\u819c\uff0cdsDNA\uff0c120-200\t\t\tnm<\/span><\/p>\n<\/td>\n

\n

7.4-7.8<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Reo-3<\/span><\/p>\n<\/td>\n

\n

\u547c\u80a0\u5b64\u75c5\u6bd2<\/span><\/p>\n<\/td>\n

\n

\u65e0\u5305\u819c\uff0cdsRNA\uff0c50-70\t\t\tnm<\/span><\/p>\n<\/td>\n

\n

3.9<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/h1>\n
\n
\n
4.\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u8bd5\u9a8c<\/section>\n<\/section>\n<\/section>\n

\u4f46\u662f\u5bf9\u5927\u89c4\u6a21\u751f\u4ea7\u7684\u75c5\u6bd2\u706d\u6d3b\u548c\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u7684\u7814\u7a76\uff0c\u7531\u4e8e\u53d7\u9650\u4e8e\u53ef\u63d0\u4f9b\u7814\u7a76\u7684\u75c5\u6bd2\u91cf\u53ca\u5176\u4ed6\u6761\u4ef6\uff0c\u53ea\u80fd\u91c7\u7528\u4f7f\u7528\u7f29\u5c0f\u89c4\u6a21\u751f\u4ea7\u7684\u529e\u6cd5\u6765\u8fdb\u884c\u7814\u7a76\uff0c\u5176\u4e2d\u4e00\u79cd\u65b9\u6cd5\u662f\u5bf9\u6bcf\u4e00\u4e2a\u64cd\u4f5c\u5355\u5143\u91c7\u7528\u771f\u6b63\u7ebf\u6027\u653e\u5927\u7684\u7f29\u51cf\u89c4\u6a21\u7684\u6a21\u5f0f\uff0c\u4f7f\u5176\u63d0\u4f9b\u7684\u6570\u636e\u8db3\u4ee5\u4ee3\u8868\u5927\u89c4\u6a21\u751f\u4ea7\u7684\u60c5\u51b5\uff0c\u4ee5\u6b64\u7814\u7a76\u6765\u786e\u4fdd\u751f\u7269\u6280\u672f\u4ea7\u54c1\u7684\u5b89\u5168\u6027\uff0c\u91c7\u7528\u6b64\u6a21\u5f0f\u8fdb\u884c\u6e05\u9664\u75c5\u6bd2\u7814\u7a76\uff0c\u9996\u5148\u662f\u8bbe\u8ba1\u5e76\u89c4\u8303\u5c0f\u89c4\u6a21\u751f\u4ea7\u8fc7\u7a0b\u7684\u6a21\u578b\uff0c\u5e76\u5c3d\u53ef\u80fd\u63a5\u8fd1\u5b9e\u9645\u751f\u4ea7\u6c34\u5e73\uff0c\u4f8b\u5982\uff0c\u67f1\u5e8a\u9ad8\u5ea6\u3001\u6d41\u901f\u3001\u8f7d\u91cf\u3001\u4fdd\u7559\u65f6\u95f4\u3001\u7f13\u51b2\u6db2\u7528\u91cf\u3001\u586b\u6599\u578b\u53f7\u3001pH\u3001\u6e29\u5ea6\u3001\u86cb\u767d\u6d53\u5ea6\u3001\u6eb6\u6db2\u79bb\u5b50\u5f3a\u5ea6\u3001\u8fc7\u6ee4\u901f\u5ea6\u3001\u538b\u529b\u548c\u8fc7\u6ee4\u91cf\u3002<\/span><\/p>\n

\u76ee\u524d\u56fd\u5185\u5e38\u7528\u7684\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u5b9e\u9a8c\u7684\u65b9\u6848\u8868 2\u3002<\/span><\/p>\n

\u88682 \u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u65b9\u6848<\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5de5\u827a<\/strong><\/span><\/p>\n<\/td>\n

\n

\u4e00\u671f\u7533\u62a5<\/strong><\/span><\/p>\n<\/td>\n

\n

\u4e09\u671f\u7533\u62a5<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

NMPA<\/strong><\/span><\/p>\n<\/td>\n

\n

EMPA,\t\t\tTGA, US FDA<\/strong><\/span><\/p>\n<\/td>\n

\n

EMPA,\t\t\tTGA, US FDA<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4f4epH\u75c5\u6bd2\u706d\u6d3b\u6216\u53bb\u57a2\u5242\u706d\u6d3b<\/span><\/p>\n<\/td>\n

\n

2\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tPRV\uff09\uff0c\u4e09\u6279\uff0c\u52a8\u6001\u66f2\u7ebf<\/span><\/p>\n<\/td>\n

\n

1\u79cd\u75c5\u6bd2\uff08MuLV\uff09\uff0c1\u6279GMP\uff0c\u91cd\u590d\u5b9e\u9a8c<\/span><\/p>\n<\/td>\n

\n

2\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tPRV\uff09\uff0c\u91cd\u590d\u5b9e\u9a8c<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7eb3\u6ee4<\/span><\/p>\n<\/td>\n

\n

2\u79cd\u75c5\u6bd2(MVM\uff0c\t\t\tReo-3\uff09\uff0c\u4e09\u6279\uff0c\u4e2d\u95f4\u53d6\u6837<\/span><\/p>\n<\/td>\n

\n

2\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tMVM\uff09\uff0c1\u6279GMP\uff0c\u91cd\u590d\u5b9e\u9a8c\uff0cMVM\u5b9e\u9a8c\u4e2d\u9700\u8981\u4e2d\u95f4\u53d6\u6837<\/span><\/p>\n<\/td>\n

\n

4\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tMVM\uff0cReo-3\uff0cPRV\uff09\uff0c\u91cd\u590d\u5b9e\u9a8c\uff0cMVM\u5b9e\u9a8c\u4e2d\u9700\u8981\u4e2d\u95f4\u53d6\u6837<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790<\/span><\/p>\n<\/td>\n

\n

NA<\/span><\/p>\n<\/td>\n

\n

2\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tMVM\uff09\uff0c1\u6279GMP\uff0c\u91cd\u590d\u5b9e\u9a8c<\/span><\/p>\n<\/td>\n

\n

4\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tMVM\uff0cReo-3\uff0cPRV\uff09\uff0c\u91cd\u590d\u5b9e\u9a8c\uff0c\u8bc4\u4f30\u8bbe\u5b9a\u7684\u6700\u5927\u4f7f\u7528\u6b21\u6570\u65f6\u7684\u586b\u6599<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u53e6\u5916\u4e00\u79cd\u5c42\u6790\u6b65\u9aa4<\/span><\/p>\n<\/td>\n

\n

NA<\/span><\/p>\n<\/td>\n

\n

\u9009\u62e9\u53e6\u5916\u4e00\u79cd\u5c42\u6790\u6b65\u9aa4<\/span><\/p>\n<\/td>\n

\n

4\u79cd\u75c5\u6bd2\uff08MuLV\uff0c\t\t\tMVM\uff0cReo-3\uff0cPRV\uff09\uff0c\u91cd\u590d\u5b9e\u9a8c\uff0c\u8bc4\u4f30\u8bbe\u5b9a\u7684\u6700\u5927\u4f7f\u7528\u6b21\u6570\u65f6\u7684\u586b\u6599<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/h1>\n
\n
\n
5.\u4e0b\u6e38\u7eaf\u5316\u5404\u5de5\u827a\u5bf9\u4e8e\u75c5\u6bd2\u6d88\u9664\u3001\u706d\u6d3b\u6548\u679c\u7684\u7814\u7a76<\/section>\n<\/section>\n<\/section>\n

<\/h1>\n

5.1 \u6f84\u6e05\u6df1\u5c42\u8fc7\u6ee4<\/span><\/strong><\/h1>\n

\u867d\u7136\u6f84\u6e05\u6df1\u5c42\u8fc7\u6ee4\u819c\u5177\u6709\u5927\u8868\u9762\u79ef\u53ca\u5438\u9644\u6027\u7684\u8868\u5c42\u7684\u7279\u70b9\uff0c\u5e76\u4e14\u80fd\u5438\u9644\u57f9\u517b\u4e0a\u6e05\u6db2\u4e2d\u7684\u6742\u8d28\u4ece\u800c\u63d0\u9ad8\u4e0b\u6e38\u7684\u7eaf\u5316\u6548\u7387\uff0c\u6709\u6587\u732e\uff08AbhinavA Shukla, 2015\uff09\u6307\u51fa\uff0c\u4f7f\u7528A1HC\u548cCuno90ZA\u8fdb\u884c\u6f84\u6e05\u6df1\u5c42\u8fc7\u6ee4\uff0c\u53ef\u4ee5\u8fbe\u52302- 4LRV\u7684\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\uff0c\u4f46\u662f\u76ee\u524d\u6df1\u5c42\u8fc7\u6ee4\u672a\u88ab\u9009\u7528\u4e8e\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u5b9e\u9a8c\u4e2d\uff0c\u90e8\u5206\u539f\u56e0\u662f\u6df1\u5c42\u8fc7\u6ee4\u662f\u5728\u4f4e\u538b\u4e0b\u8fdb\u884c\u5b9e\u9a8c\uff0c\u5b9e\u9645\u64cd\u4f5c\u4e2d\u6d41\u4f53\u5206\u5e03\u548c\u5c0f\u89c4\u6a21\u7684\u819c\u4e2d\u7684\u5206\u5e03\u662f\u5426\u4e00\u81f4\uff0c\u662f\u5426\u80fd\u591f\u7a33\u5065\u7684\u7528\u4e8e\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u5c1a\u672a\u53ef\u77e5\u3002<\/span><\/p>\n

5.2 \u4eb2\u548c\u5c42\u6790<\/span><\/strong>
<\/p>\n

\u6839\u636e\u6587\u7ae0\uff08Luteet al.,2008\uff09\u4e2d\u7814\u7a76\uff0c\u4f7f\u7528\u4eb2\u548c\u5c42\u6790\u6d88\u9664\u75c5\u6bd2\u4e3b\u8981\u4f9d\u9760\u75c5\u6bd2\u5728\u4eb2\u548c\u586b\u6599\u4e2d\u548c\u5176\u4ed6\u975e\u76ee\u6807\u86cb\u767d\u7684\u6742\u8d28\u53d1\u9175\u6db2\u6210\u5206\u4e00\u8d77\u6d41\u7a7f\uff0c\u5e76\u4e14\u4e0d\u53d7\u586b\u6599\u5bff\u547d\u7684\u5f71\u54cd\uff0c\u53e6\u5916\u4e00\u7bc7\u6587\u7ae0\uff08Georgeet al.,2010\uff09\u4e2d\u6307\u51fa\uff0c\u4eb2\u548c\u5c42\u6790\u6d88\u9664\u75c5\u6bd2\u7684\u80fd\u529b\u4e5f\u53d7\u5404\u79cd\u4eb2\u548c\u5de5\u827a\u53c2\u6570\uff08\u8f7d\u91cf\u3001\u7f13\u51b2\u6db2\u4f53\u7cfb\u3001\u4fdd\u7559\u65f6\u95f4\u7b49\uff09\u7684\u5f71\u54cd\u4e0d\u5927\uff0c\u4f46\u662f\u57f9\u517b\u6536\u83b7\u6db2\u7684\u6d53\u5ea6\u6216\u8005\u7c7b\u578b\u5bf9\u5176\u5f71\u54cd\u8f83\u5927\uff08titer\u9ad8\u4f4e\u3001\u5206\u5b50\u5e8f\u5217\u7b49\uff09\u3002\u5f53\u75c5\u6bd2\u975e\u7279\u5f02\u6027\u7684\u5438\u9644\u5230\u586b\u6599\u6216\u548c\u76ee\u6807\u86cb\u767d\uff0c\u53ef\u80fd\u4f1a\u964d\u4f4e\u75c5\u6bd2\u6e05\u9664\u7684\u80fd\u529b\uff0c<\/span><\/p>\n

\u4ece\u56fe 3(a)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u4f7f\u7528\u4eb2\u548c\u5c42\u6790\u6d88\u9664\u9006\u8f6c\u5f55\u75c5\u6bd2\u7684\u80fd\u529b\u7ea670% \u7ef4\u6301\u57284 – 6LRV\uff0c\u4f46\u4eceKathryn\u7b49\u4eba\u7684\u6587\u7ae0\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u4eb2\u548c\u5c42\u6790\u6d88\u9664X-MuLV\u7684\u5e73\u5747\u6c34\u5e732.98LRV\uff0c\u6d88\u9664MMV\u7684\u5e73\u5747\u6c34\u5e73\u4e3a2.32LRV\u3002MinZhang\u7684\u6587\u7ae0\u4e2d\u6307\u51fa\u4eb2\u548c\u5c42\u6790\u6d88\u9664X-MuLV\u548cMMV\u7684\u80fd\u529b\u5177\u6709\u540c\u6837\u7684\u8d8b\u52bf\uff0c\u6bd4\u5982\uff0c\u5f53\u6d88\u9664X-MuLV\u7684\u80fd\u529b\u63d0\u9ad8\u65f6\uff0c\u6d88\u9664MMV\u7684\u80fd\u529b\u540c\u6837\u63d0\u9ad8\uff0c\u4f46\u662f\u603b\u4f53\u6765\u8bf4\uff0c\u6d88\u9664X-MuLV\u7684\u80fd\u529b\u5927\u4e8e\u6d88\u9664MMV\u7684\u80fd\u529b\uff0c\u5927\u7ea6\u9ad80.7LRV\u3002<\/span><\/p>\n

Scott Lute\u7b49\u4eba\u901a\u8fc7\u4e0d\u7528\u7684\u6e05\u6d17\u65b9\u6cd5\u5bf9\u4e0d\u540c\u4eb2\u548c\u5c42\u6790\u586b\u6599\u8fdb\u884c\u6e05\u6d17\uff0c\u5e76\u5bf9\u4f7f\u7528\u524d\u540e\u7684\u586b\u6599\u8fdb\u884c\u6bd4\u8f83\uff0c\u6240\u7528\u7684\u6a21\u578b\u75c5\u6bd2\u4e3aX-MuLV,SV40\u53caMMV\uff0c\u7814\u7a76\u8868\u660e\uff0c\u65b0\u7684\u4eb2\u548c\u586b\u6599\u548c\u591a\u6b21\u4f7f\u7528\u540e\u7684\u4eb2\u548c\u586b\u6599\u5728\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u5e76\u65e0\u5dee\u5f02\uff0c\u603b\u800c\u8a00\u4e4b\uff0c\u4eb2\u548c\u586b\u6599\u4f7f\u7528\u540e\u5e76\u4e0d\u5f71\u54cd\u6e05\u9664\u9a8c\u8bc1\u6548\u679c\u3002\u4f46\u6b27\u6d32\u56fd\u5bb6\u5bf9\u8fd9\u4e2a\u7ed3\u8bba\u6301\u4e0d\u80af\u5b9a\u6001\u5ea6\uff0c\u9700\u8981\u548c\u76f8\u5173\u90e8\u95e8\u8fdb\u884c\u8ba8\u8bba\u3002<\/span><\/p>\n

5.3 \u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u6d41\u7a7f\u6a21\u5f0f\uff09<\/span><\/strong>
<\/p>\n

\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u6d41\u7a7f\u6a21\u5f0f\uff09\u80fd\u591f\u6709\u6548\u6d88\u9664\u5177\u6709\u5305\u819c\u548c\u975e\u5305\u819c\u7684\u75c5\u6bd2\u5927\u4e8e4LRV\uff0c\u4ece\u56fe 3(b)\u4e2d\u53ef\u4ee5\u770b\u51fa\u7ea6\u670934%\u7684\u6848\u4f8b\uff0c\u4f7f\u7528\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\u6d88\u9664\u9006\u8f6c\u5f55\u75c5\u6bd2\u7684\u80fd\u529b\u7ef4\u6301\u57285- 6 LRV\u3002\u6d88\u9664X-MuLV\u7684\u5e73\u5747\u6c34\u5e734.22LRV\uff0c\u6d88\u9664MMV\u7684\u5e73\u5747\u6c34\u5e73\u4e3a3.25LRV\u3002<\/span><\/p>\n

Strauss\u7b49\u5728\u6587\u4e2d\u6307\u51fa\u4e0a\u6837\u6837\u54c1\u7684pH\u548c\u7535\u5bfc\u7387\u4f1a\u5f71\u54cd\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u6d41\u7a7f\u6a21\u5f0f\uff09\u6d88\u9664\u75c5\u6bd2\u7684\u80fd\u529b\uff0c\u6587\u4e2d\u4f7f\u7528QSFF\u548cSFF\uff08\u4e0d\u542b\u6709\u5e26\u7535\u57fa\u56e2\uff09\u586b\u6599\uff0c\u67d0\u79cd\u5355\u6297\uff08pI\u5927\u4e8e8.0\uff09\u4f5c\u4e3a\u7814\u7a76\u86cb\u767d\uff0c\u5e76\u4f7f\u7528X-MuLV,SV40\u53caMMV\u4f5c\u4e3a\u6a21\u578b\u75c5\u6bd2\uff0c\u5e76\u4ee5pH8.0\u4e0d\u540c\u76d0\u6d53\u5ea6\u4f5c\u4e3a\u7814\u7a76\u6761\u4ef6\uff0c\u4ece\u56fe 4(c)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u5728\u5b9e\u9a8c\u6761\u4ef6\u4e0b\uff0c\u5e26\u5b63\u94f5\uff08QSFF\uff09\u7684\u586b\u6599\u6bd4\u4e0d\u542b\u5e26\u7535\u57fa\u56e2\u7684\u586b\u6599\u5177\u6709\u66f4\u9ad8\u7684\u53bb\u75c5\u6bd2\u7684\u80fd\u529b\uff0c\u7814\u7a76\u5f97\u51fa\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\u6d88\u9664\u75c5\u6bd2\u7684\u80fd\u529b\u4e3b\u8981\u662f\u7531\u4e8e\u9759\u7535\u4f5c\u7528\u4f5c\u4e3a\u4e3b\u5bfc\u4f5c\u7528\uff0c\u56e0\u4e3a\u5728pH8.0\u6761\u4ef6\u4e0b\uff0c\u75c5\u6bd2\u5e26\u8d1f\u7535\u8377\uff0c\u53ef\u4ee5\u548c\u5e26\u6b63\u7535\u8377\u7684\u5b63\u94f5\u9633\u79bb\u5b50\u7ed3\u5408\uff0c\u4ece\u800c\u8fbe\u5230\u6d88\u9664\u75c5\u6bd2\u7684\u4f5c\u7528\uff0c\u4f46\u662f\u8fd9\u79cd\u9759\u7535\u4f5c\u7528\u4f1a\u88ab\u9ad8\u76d0\u6761\u4ef6\u6253\u7834\uff0c\u4ece\u56fe 4(a)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u5f53\u4e0a\u6837\u76d0\u6d53\u5ea6\u4ece25mM\u5347\u9ad8\u81f31 MNaCl\u65f6\uff0c\u4e09\u79cd\u75c5\u6bd2\u7684\u6d88\u9664\u80fd\u529b\u5747\u4e0b\u964d\uff0cX-MuLV\u4ece4.6LRV\u964d\u4e3a1.0LRV\uff0cSV40\u4ece4.2LRV\u964d\u4e3a\u4e861.0LRV\uff0cMMV\u4ece4.8LRV\u964d\u4e3a\u4e860.1LRV\uff0c\u4ece\u56fe 4(b)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u5f53\u4e0a\u6837\u7535\u5bfc\u7387\u589e\u81f350mS\/cm\u65f6\uff0c\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u964d\u4f4e\u81f31.0LRV\u4ee5\u4e0b\uff0c\u4ece\u800c\u8bf4\u660e\u9759\u7535\u4f5c\u7528\u4f1a\u88ab\u9ad8\u76d0\u6761\u4ef6\u6253\u7834\u3002\u53e6\u5916\u4e00\u7bc7\u6587\u7ae0\u4e2d\uff08CurtisS,2003\uff09\uff0c\u4ee5QSFF\u4f5c\u4e3a\u5c42\u6790\u586b\u6599\uff0cSV40\u4f5c\u4e3a\u6a21\u578b\u75c5\u6bd2\uff0c\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u7684\u4e09\u79cd\u6297\u4f53\u4e3a\u76ee\u6807\u86cb\u767d\uff0c\u901a\u8fc7\u5bf9\u5c42\u6790\u8fc7\u7a0b\u67f1\u9ad8\uff0c\u7ebf\u6027\u6d41\u901f\uff0c\u4e0a\u6837\u8f7d\u91cf\uff0cpH\u53ca\u7535\u5bfc\u7387\u7684\u7814\u7a76\uff0c\u5f97\u51fa\u7ed3\u8bba\uff0c\u5f53\u7ebf\u6027\u6d41\u901f76-600cm\/h\uff0c\u7f13\u51b2\u6db2\u4f53\u7cfb\u4e3aTris-base\u4f53\u7cfb\uff0c\u64cd\u4f5c\u6e29\u5ea6\u4e3a\u5ba4\u6e29\uff0c\u5c42\u6790\u67f1\u9ad8\u226511 cm\uff0c\u64cd\u4f5c\u8f7d\u91cf\u4e3a\u2264250 g\/L\u65f6\uff0c\u53ef\u6d88\u9664SV40\u8fbe\u5230\u22654.7 LRV\u3002<\/span><\/p>\n

LisaConnell-Crowley\uff082013\uff09\u7b49\u4f7f\u7528Tecan\u8fdb\u884c\u9ad8\u901a\u91cf\u7b5b\u9009\uff0c\u786e\u8ba4pH\u5bf9\u9634\u79bb\u5b50\u5c42\u6790\u7684\u5f71\u54cd\u5c0f\u4e8eNaCl\uff08\u76d0\u6d53\u5ea6\uff09\u5bf9\u9634\u79bb\u5b50\u5c42\u6790\u53bb\u75c5\u6bd2\u7684\u5f71\u54cd\u3002\u5b9e\u9a8c\u4e2d\u4f7f\u7528QSFF\u548cCaptoadhere\u4f5c\u4e3a\u5b9e\u9a8c\u6750\u6599\uff0cX-MuLV\u4f5c\u4e3a\u76ee\u6807\u75c5\u6bd2\uff0c\u7814\u7a76\u53d1\u73b0\uff0c\u9759\u7535\u4f5c\u7528\u662f\u4fc3\u4f7f\u75c5\u6bd2\u7ed3\u5408\u4e8e\u9634\u79bb\u5b50\u586b\u6599\u7684\u4e3b\u8981\u539f\u56e0\uff0c\u5bf9\u4e8eQSFF\uff0c\u4f4e\u76d0\u6761\u4ef6\uff08\u2264100 mM NaCl\uff09\u80fd\u591f\u8fbe\u5230\u8f83\u9ad8\u7684\u6d88\u9664\u6548\u679c\u3002\u5bf9\u4e8eCaptoadhere\u586b\u6599\uff0c\u540c\u6837\u662f\u9759\u7535\u4f5c\u7528\u5360\u636e\u4e3b\u8981\u539f\u56e0\uff0c\u4f46\u662f\u758f\u6c34\u4f5c\u7528\uff0c\u6c22\u952e\u4e5f\u53d1\u6325\u4f5c\u7528\uff0c\u76f8\u5bf9\u4e8eQSFF\uff0cCaptoadhere\u5728\u542b\u6709200mM NaCl\u4e2d\u6d88\u9664\u75c5\u6bd2\u7684\u80fd\u529b\u5927\u4e8eQSFF\uff0c\u4e5f\u5c31\u662f\u8bf4Captoadhere\u66f4\u8010\u76d0\u3002\u540c\u65f6\u5b9e\u9a8c\u4e5f\u8868\u660e\uff0c\u6837\u54c1\u4e2d\u6742\u8d28\u7684\u542b\u91cf\uff08HCP,DNA, HMW\u7b49\uff09\u4f1a\u548c\u75c5\u6bd2\u7ade\u4e89\u5438\u9644Captoadhere\u548cQSFF\u586b\u6599\uff0c\u4ece\u800c\u5bfc\u81f4\u6d88\u9664\u75c5\u6bd2\u80fd\u529b\u7684\u4e0b\u964d\u3002<\/span><\/p>\n

5.4 \u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u819c\u5c42\u6790\uff09<\/span><\/strong>
<\/p>\n

\u867d\u7136\u76ee\u524d\u9634\u79bb\u5b50\u4ea4\u6362\u819c\u5c42\u6790\u5728\u56fd\u5185\u7684\u4f7f\u7528\u5e76\u4e0d\u5e7f\u6cdb\u3002\u4f46Miesegaes\uff082010\uff09\u7b49\u4eba\u91c7\u7528\u591a\u5bb6\u7684\u9634\u79bb\u5b50\u5438\u9644\u819c\u548c\u9634\u79bb\u5b50\u5c42\u6790\u586b\u6599\u8fdb\u884c\u6bd4\u8f83\uff0c\u53d1\u73b0\u4e24\u8005\u5177\u6709\u540c\u7b49\u7684\u75c5\u6bd2\u6d88\u9664\u6548\u679c\uff0c\u4f8b\u5982\u4e24\u8005\u5927\u7ea6\u6d88\u9664X-MuLV\u8fbe\u52304LRV\uff0c\u5438\u9644\u819c\u7684\u914d\u57fa\u548c\u75c5\u6bd2\u5e26\u7535\u91cf\u5bf9\u4e8e\u6d88\u9664\u6548\u679c\u5f71\u54cd\u8f83\u5927\uff0c\u800c\u6d41\u901f\u3001\u4fdd\u7559\u65f6\u95f4\u5219\u5bf9\u75c5\u6bd2\u7684\u6d88\u9664\u6548\u679c\u5f71\u54cd\u4e0d\u5927\uff0c<\/span><\/p>\n

5.5 \u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u7ed3\u5408\u6a21\u5f0f\uff09<\/span><\/strong>
<\/p>\n

\u56fe 3(d)\u4e2d\u53ef\u4ee5\u770b\u51fa\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u7ed3\u5408\u6a21\u5f0f\uff09\u6d88\u9664\u75c5\u6bd2LRV\u5e7f\u6cdb\u5206\u5e03\u4e8e3- 7 LRV\uff0c\u56fe 5(c &d)\u5c55\u793a\u4e86\u9634\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u7ed3\u5408\u6a21\u5f0f\uff09\u53bb\u75c5\u6bd2\u80fd\u529b\u4e0epH\u548c\u76d0\u6d53\u5ea6\u7684\u5173\u7cfb\uff0c\u4ece\u56fe 5(c)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u76f8\u5bf9\u4e8e\u4e0a\u6837\/\u5e73\u8861\u548c\u6d17\u8131\u6db2\u4e4b\u95f4\u540c\u6837\u7684pH\u7684\u5b9e\u9a8c\u4e2d\uff0c\u4e24\u8005\u4e4b\u95f4\u6709pH\u5dee\u5f02(0.6)\u6709\u52a9\u4e8e\u63d0\u9ad8\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\uff0c\u56fe 5(d)\u4e2d\u5c55\u793a\u4e86\u5f53\u4e0a\u6837\/\u5e73\u8861\u548c\u6d17\u8131\u6db2\u4e4b\u95f4\u76d0\u6d53\u5ea6\u5dee\u5f02\u8f83\u5927\u65f6\u4e0d\u5229\u6d88\u9664\u75c5\u6bd2\u3002George\u7684\u6587\u4e2d\u6307\u51fa\uff0c\u5f53\u76ee\u6807\u86cb\u767d\u7684pI\u548c\u75c5\u6bd2\u7684\u7b49\u7535\u70b9\u63a5\u8fd1\u65f6\uff0c\u4e0d\u5229\u4e8e\u75c5\u6bd2\u6d88\u9664\u3002<\/span><\/p>\n

5.6 \u9633\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u7ed3\u5408\u6a21\u5f0f\uff09<\/span><\/strong>
<\/p>\n

\u4ece\u56fe 3(c)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u9633\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\uff08\u7ed3\u5408\u6a21\u5f0f\uff09\u6d88\u9664\u75c5\u6bd2\u7684\u80fd\u529b\u4e0d\u5747\uff0c\u7ea620% \u80fd\u591f\u6d88\u96641\u2013 2 LRV\uff0c\u540c\u65f6\u4e5f\u6709\u7ea68%\u7ef4\u6301\u57286 – 7LRV\uff0c\u4f46\u4eceKathryn\u7b49\u4eba\u7684\u6587\u7ae0\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u9633\u79bb\u5b50\u5c42\u6790\u6d88\u9664X-MuLV\u7684\u5e73\u5747\u6c34\u5e732.51LRV\uff0c\u6d88\u9664MMV\u7684\u5e73\u5747\u6c34\u5e73\u4e3a0.92LRV\u3002\u56fe 5(a)\u4e2d\u4e5f\u53ef\u4ee5\u770b\u51fa\uff0c\u4e0a\u6837\/\u5e73\u8861\u548c\u6d17\u8131\u65f6\u4f7f\u7528\u4e86\u4f4epH\u7684\u7f13\u51b2\u6db2\u65f6\uff0c\u80fd\u591f\u53d6\u5f97\u8f83\u9ad8\u7684LRV\uff0c\u4ece\u56fe 5(b)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u5728\u4e0a\u6837\/\u5e73\u8861\u548c\u6d17\u8131\u65f6\u4f7f\u7528\u8f83\u4f4e\u7684\u76d0\u6d53\u5ea6\uff0c\u540c\u65f6\u6709\u52a9\u4e8e\u63d0\u9ad8\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u3002<\/span><\/p>\n

5.7 \u7eb3\u6ee4<\/span><\/strong>
<\/p>\n

\u4ece\u56fe 3(h&i)\u4e2d\u6307\u51fa\uff0c\u5bf9\u4e8e\u6d88\u9664\u9006\u8f6c\u5f55\u75c5\u6bd2\uff0c\u65e0\u8bba\u4f7f\u7528\u5927\u5b54\u7eb3\u6ee4\u819c\u8fd8\u662f\u5c0f\u5b54\u7eb3\u6ee4\u819c\uff0c\u5747\u80fd\u8fbe\u52302LRV\u4ee5\u4e0a\u7684\u6d88\u9664\u80fd\u529b\uff0c\u4f46\u662f\u5bf9\u4e8e\u7ec6\u5c0f\u75c5\u6bd2\u7684\u6d88\u9664\u80fd\u529b\uff0c\u4ece\u56fe 3(j)\u4e2d\u53ef\u4ee5\u770b\u51fa\uff0c\u4f7f\u7528\u5c0f\u5b54\u7eb3\u6ee4\u819c\u6d88\u9664\u7ec6\u5c0f\u75c5\u6bd2\uff0c\u53d1\u73b0\u4e86\u4f4e\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u7684\u6848\u4f8b\uff0c\u53ef\u80fd\u662f\u7531\u4e8e\u7eb3\u6ee4\u819c\u7684\u7c7b\u578b\u9020\u6210\u7684\uff08\u6587\u4e2d\u5e76\u672a\u6307\u51fa\u4f7f\u7528\u4e86\u54ea\u79cd\u7eb3\u6ee4\u819c\uff09\uff0cPDA\uff082008\uff09\u4e2d\u6307\u51fa\uff0c\u4f7f\u7528\u5c0f\u5b54\u7eb3\u6ee4\u819c\u6d88\u9664\u7ec6\u5c0f\u75c5\u6bd2\u8981\u9632\u6b62\u56e0\u8fc7\u8f7d\u800c\u5f15\u8d77\u7684\u6d41\u7a7f\u3002<\/span><\/p>\n

\u7eb3\u6ee4\u7684\u8f7d\u91cf\u548c\u6ee4\u819c\u88ab\u6c61\u67d3\u7684\u7a0b\u5ea6\u76f4\u63a5\u76f8\u5173\uff0c\u5728\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u65f6\uff0c\u75c5\u6bd2\u7684\u7eaf\u5ea6\u975e\u5e38\u91cd\u8981\uff0c\u7eaf\u5ea6\u8d8a\u9ad8\uff0c\u75c5\u6bd2\u6d88\u9664\u65f6\u7684\u5b9e\u9645\u8f7d\u91cf\u53ef\u80fd\u8d8a\u9ad8\uff0c\u5e76\u4e14\u901a\u5e38\u60c5\u51b5\u4e0b\uff0cMVM\u75c5\u6bd2\u7684\u7eaf\u5ea6\u9ad8\u4e8eX-MuLV\uff0c\u5927\u5c0f\u65b9\u9762\uff1aMVM\u5c0f\u4e8eX-MuLV\uff0c\u56e0\u6b64\u7eb3\u6ee4\u6d88\u9664\u75c5\u6bd2\u7684\u6548\u679c\u53ef\u4f7f\u7528MVM\u7684\u6d88\u9664\u7a0b\u5ea6\u4f5c\u4e3a\u6700\u5dee\u60c5\u51b5\u3002<\/span><\/p>\n

\u76ee\u524d\u53d1\u73b0\uff0cPlanova20N\u7684\u7eb3\u6ee4\u819c\u7684\u4f4e\u8f7d\u91cf\u53ef\u80fd\u662f\u7531\u4e8e\u86cb\u767d\u6eb6\u6db2\u5f15\u8d77\u7684\uff0c\u4f8b\u5982\u86cb\u767d\u6eb6\u6db2\u7684\u805a\u4f53\u542b\u91cf\uff0c\u8fd9\u4e2a\u53ef\u901a\u8fc7\u9884\u8fc7\u6ee4\u5668\u5b9e\u73b0\u3002\u4f4e\u538b\u64cd\u4f5c\u8fc7\u6ee4\uff086.5psi\uff09\u6216\u8005\u4e2d\u95f4\u6d41\u901f\u6682\u505c\uff0c\u53ef\u80fd\u4f1a\u9020\u6210\u75c5\u6bd2\u6d41\u7a7f\uff0c\u867d\u7136\u76ee\u524d\u8fd9\u4e2a\u73b0\u8c61\u672a\u51fa\u73b0\u5728BioEX\u6ee4\u819c\u4e2d\uff0c\u4f46\u662f\u4f4e\u538b\u60c5\u51b5\u7684\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u6548\u679c\uff0c\u9700\u8981\u8fdb\u884c\u6d4b\u5b9a\uff0c\u5e76\u4e14\u82e5\u4f7f\u7528Planova20N\uff0c\u5728\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u65f6\uff0c\u662f\u5426\u9700\u8981\u6a21\u62df\u751f\u4ea7\u4e2d\u7684\u5b9e\u9645\u6d41\u901f\u72b6\u51b5\uff0c\u4f8b\u5982\u6682\u505c\uff0c\u5e94\u5f15\u8d77\u8db3\u591f\u91cd\u89c6\u3002<\/span><\/p>\n

\u76ee\u524d\u5b58\u5728\u4e00\u79cd\u731c\u60f3\uff0c\u5728\u7eb3\u6ee4\u65f6\uff0c\u5c0f\u5b54\u5f84\u7684\u819c\u5305\u6700\u5148\u88ab\u6742\u8d28\u5835\u585e\uff0c\u5bfc\u81f4\u75c5\u6bd2\u4ece\u5927\u5b54\u5f84\u6d41\u7a7f\uff0c\u8fd9\u79cd\u4f18\u5148\u5835\u585e\u539f\u7406\uff0c\u53cd\u6620\u5728\u6d41\u901f\u8870\u51cf\u4e2d\uff0c\u6240\u4ee5\u5efa\u8bae\u65e0\u8bba\u5728\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u8fd8\u662f\u5b9e\u9645\u64cd\u4f5c\u4e2d\uff0c\u4ee5\u6d41\u901f\u8870\u51cf\u91cf\u4f5c\u4e3a\u7ed3\u675f\u7ec8\u70b9\uff0c\u4f46\u76ee\u524d\u5927\u90e8\u5206\u7ec4\u7ec7\u4ecd\u4ee5\u4f53\u79ef\u8f7d\u91cf\u4f5c\u4e3a\u7ec8\u70b9\u3002<\/span><\/p>\n

5.8 \u4f4epH\u75c5\u6bd2\u706d\u6d3b<\/span><\/strong>
<\/p>\n

\u5e38\u9009\u7528\u8f83\u5f31\u7684\u9178\u8fdb\u884c\u4f4epH\u75c5\u6bd2\u706d\u6d3b\uff0c\u4ece\u800c\u53ef\u9632\u6b62\u9ad8\u6d53\u5ea6\u7684\u9178\u9020\u6210\u7684\u5c40\u90e8\u6d53\u5ea6\u8fc7\u9ad8\uff0c\u5bfc\u81f4\u4ea7\u751f\u805a\u4f53\u6216\u8005\u5176\u4ed6\u5f71\u54cd\u8d28\u91cf\u7684\u53ef\u80fd\u6027\u95ee\u9898\uff0c\u5f31\u78b1\u6eb6\u6db2\u901a\u5e38\u5728\u6b65\u9aa4\u5b8c\u6210\u540e\u7528\u4e8e\u4e2d\u548c\uff0c\u56e0\u4e3a\u957f\u65f6\u95f4\u66b4\u9732\u5728\u4f4epH\u6761\u4ef6\u4e0b\u662f\u4e0d\u53ef\u53d6\u7684\u3002\u56fe 3(c)\u4e2d\u5c55\u793a\u51fa\u7ea6\u670941%\u7684\u6848\u4f8b\u5e76\u4e0d\u80fd\u5b8c\u5168\u6e05\u9664\u75c5\u6bd2\uff0cpH\u662f\u4f4epH\u75c5\u6bd2\u706d\u6d3b\u7684\u4e00\u4e2a\u5173\u952e\u5de5\u827a\u53c2\u6570\uff0c\u867d\u7136Brorson\u7b49\u4eba\u6307\u51fapH3.8\u8db3\u591f\u706d\u6d3b\u9006\u8f6c\u5f55\u75c5\u6bd2\uff0c\u5e76\u4e14\u6839\u636eGeorge\u7b49\u4eba\u7684\u6587\u4e2d\u6307\u51fa\u5728pH3.6\u6216\u8005\u66f4\u4f4e\u7684pH\u73af\u5883\u4e2d\u65b9\u80fd\u4fdd\u8bc1\u75c5\u6bd2\u7684\u706d\u6d3b\u80fd\u529b\u3002\u6eb6\u6db2\u6d53\u5ea6\u662f\u53e6\u5916\u4e00\u4e2a\u5173\u952e\u6027\u56e0\u7d20\uff0c\u4f46\u662f\u5f53\u6eb6\u6db2\u76d0\u6d53\u5ea6\u2264500 mM NaCl\uff0c\u6d53\u5ea6\u226440 mg\/mL\uff0cpH\u2264 3.8\uff0c\u53ef\u4ee5\u8fbe\u5230\u6d88\u9664\u22654.6 LRV\u7684\u9006\u8f6c\u5f55\u75c5\u6bd2\u7684\u6548\u679c\u3002<\/span><\/p>\n

\u76ee\u524d\u5bf9\u4e8e\u4f4epH\u75c5\u6bd2\u706d\u6d3b\uff0c\u5177\u6709\u4e00\u4e2a\u5f85\u89e3\u51b3\u7684\u7591\u95ee\uff1a\u7531\u4e8e\u5bb9\u5668\u9876\u90e8\u6216\u8005\u7ba1\u9053\u58c1\u7684\u6db2\u6ef4\u672a\u80fd\u63a5\u53d7\u5230\u5f88\u597d\u7684\u4f4epH\u75c5\u6bd2\u7684\u706d\u6d3b\uff0c\u8fd9\u4e2a\u95ee\u9898\u6210\u4e3a\u201c\u60ac\u6ef4\u95ee\u9898\u201d\uff0c\u76ee\u524d\u67d0\u4e9b\u516c\u53f8\u91c7\u53d6\u7684\u65b9\u6848\u662f\u5c06\u6df7\u5300\u5b8c\u6210\u7684\u6eb6\u6db2\u8f6c\u79fb\u81f3\u53e6\u5916\u4e00\u4e2a\u5bb9\u5668\u4e2d\u3002<\/span><\/p>\n

5.9 S\/D\u75c5\u6bd2\u706d\u6d3b<\/span><\/strong>
<\/p>\n

\u4f7f\u7528S\/D\u8fdb\u884c\u75c5\u6bd2\u706d\u6d3b\u5f71\u54cd\u56e0\u7d20\u4f17\u591a\uff0c\u6bd4\u5982\u6240\u4f7f\u7528S\/D\u7684\u79cd\u7c7b\u3001\u53d1\u9175\u6db2\u7684\u6e29\u5ea6\u3001\u6d88\u6ce1\u5242\u7684\u542b\u91cf\u3001\u6d53\u5ea6\u53ca\u5176\u4e2d\u6742\u8d28\u542b\u91cf\uff0c\u9996\u5148S\/D\u7684\u79cd\u7c7b\u5f88\u591a\uff0c\u4f7f\u75280.25%\u7684TritonX-100\u5b75\u80b2\u65f6\u95f4\u5927\u4e8e30min\u4fbf\u53ef\u6709\u6548\u706d\u6d3b\u75c5\u6bd2\uff0c\u5f53\u4f7f\u75280.3%\u7684TritonX-100\u5ba4\u6e29\u5b75\u80b230min\uff0c\u53ef\u7a33\u5065\u6d88\u9664\u75c5\u6bd2\u22654 LRV\uff0c\u4f46\u662f\u5f53\u53d1\u9175\u6db2\u6e29\u5ea6\u8f83\u4f4e\u65f6\uff0cTritonX-100\u7684\u52a0\u5165\u6d53\u5ea6\u9700\u8981\u505a\u76f8\u5e94\u7684\u8c03\u6574\u3002TritonX-100\u7684\u4f7f\u7528\u4f1a\u9020\u6210\u73af\u5883\u5f71\u54cd\uff0c\u6240\u4ee5\u76ee\u524d\u9700\u8981\u614e\u7528\u3002\u53e6\u4e00\u79cd\u6f5c\u5728\u7684\u53ef\u7528\u4e8e\u75c5\u6bd2\u706d\u6d3b\u7684\u8bd5\u5242\u4e3aLDAO(Lauryldimethylamine N-oxide)\uff0c\u4f7f\u7528\u6d53\u5ea6\u4e3a014%\u4fbf\u53ef\u8fbe\u5230\u6709\u6548\u706d\u6d3b\u8102\u5305\u819c\u75c5\u6bd2\u30020.2%TnBP\u548c 1%PS80\u8054\u7528\u7528\u4e8e\u706d\u6d3b\u7ec6\u80de\u53d1\u9175\u7684\u4ea7\u54c1\u4e2d\u7684\u75c5\u6bd2\u7684\u6848\u4f8b\u4e0d\u591a\uff0c\u4f46\u5176\u5e7f\u6cdb\u7528\u4e8e\u4e8e\u8840\u6d46\u5236\u54c1\u4e2d\u3002\u65e0\u8bba\u4f7f\u7528LowpH\u8fdb\u884c\u75c5\u6bd2\u706d\u6d3b\u8fd8\u662f\u4f7f\u7528S\/D\u8fdb\u884c\u75c5\u6bd2\u706d\u6d3b\uff0c\u867d\u7136\u75c5\u6bd2\u7684\u706d\u6d3b\u6548\u679c\u663e\u8457\uff0c\u5982\u679c\u706d\u6d3b\u80fd\u529bLRV\uff1c5.2\uff0c\u6b8b\u7559\u7684\u611f\u67d3\u6027\u548c\u5bf9\u540e\u7eed\u7eaf\u5316\u6b65\u9aa4\u662f\u5426\u4ea7\u751f\u5f71\u54cd\u662f\u9700\u8981\u8003\u8651\u7684\u95ee\u9898\uff0c\u4f8b\u5982\u5f71\u54cd\u4eb2\u548c\u5c42\u6790\u7684\u5de5\u827a\u6548\u679c\uff0c\u964d\u4f4e\u4eb2\u548c\u586b\u6599\u5bff\u547d\u3002\u4e0a\u8ff0\u4f4epH\u75c5\u6bd2\u706d\u6d3b\u7684\u201c\u60ac\u6ef4\u95ee\u9898\u201d\u540c\u6837\u9002\u7528\u4e8eS\/D\u75c5\u6bd2\u706d\u6d3b\uff0c\u867d\u7136\u6db2\u6ef4\u4f4e\u843d\u540e\uff0c\u4f1a\u88ab\u6301\u7eed\u706d\u6d3b\uff0c\u4f46\u662f\u706d\u6d3b\u7684\u65f6\u95f4\u65e0\u6cd5\u4fdd\u8bc1\u3002<\/span><\/p>\n

\n
\n
6.\u5f85\u89e3\u51b3\u95ee\u9898<\/section>\n<\/section>\n<\/section>\n

\uff081\uff09\u6587\u4e2d\u63d0\u5230\u7684lowpH\u6216S\/D\u75c5\u6bd2\u706d\u6d3b\u65f6\u7684\u201c\u60ac\u6ef4\u95ee\u9898\u201d\u3002<\/span><\/p>\n

\uff082\uff09\u5f53\u57f9\u517b\u5de5\u827a\u6539\u8fdb\u540e\uff0c\u6536\u83b7\u6db2\u5bf9\u4eb2\u548c\u5c42\u6790\u7684\u75c5\u6bd2\u80fd\u529b\u4ea7\u751f\u5f71\u54cd\u7684\u7a0b\u5ea6\u3002<\/span><\/p>\n

\uff083\uff09\u590d\u5408\u6a21\u5f0f\u5c42\u6790\u586b\u6599\u6d88\u9664\u75c5\u6bd2\u7684\u539f\u7406\u662f\u5426\u548c\u758f\u6c34\u5c42\u6790\u6216\u8005\u79bb\u5b50\u4ea4\u6362\u5c42\u6790\u6b63\u4ea4\u3002<\/span><\/p>\n

\uff084\uff09\u6bcf\u79cd\u75c5\u6bd2\u7684\u91cd\u590d\u5b9e\u9a8c\u4e2d\uff0c\u4e24\u4e2a\u75c5\u6bd2\u53bb\u9664\u6570\u503c\u5e94\u8be5\u62a5\u9053\u7684\u4e24\u8005\u4e2d\u6700\u4f18\u7684\u4e00\u4e2a\uff0c\u8fd8\u662f\u6700\u5dee\u7684\u4e00\u4e2a\u6216\u4e24\u8005\u7684\u5e73\u5747\u503c\u3002<\/span><\/p>\n

\uff085\uff09\u76ee\u524d\u5021\u5bfc\u7684\u8fde\u7eed\u6d41\u7eaf\u5316\u5de5\u827a\u5982\u4f55\u8fdb\u884c\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\uff0c\u82e5\u5728\u6a21\u578b\u4e2d\u5728\u7ebf\u52a0\u5165\u75c5\u6bd2\uff0c\u5e76\u4ece\u4e2d\u95f4\u53d6\u6837\u8fdb\u884c\u75c5\u6bd2\u68c0\u6d4b\uff0c\u4f46\u4f1a\u88ab\u8d28\u7591\u6837\u54c1\u662f\u5426\u5747\u4e00\uff0c\u8fd8\u662f\u91c7\u7528\u76ee\u524d\u975e\u8fde\u7eed\u6a21\u578b\uff0c\u4f46\u4f7f\u7528\u6bcf\u79cd\u5de5\u827a\u7684\u6700\u5dee\u6761\u4ef6\u8fdb\u884c\u75c5\u6bd2\u6e05\u9664\u9a8c\u8bc1\u3002<\/span><\/p>\n

\"\u751f\u7269\u5236\u54c1\uff08\u6765\u6e90CHO\u8868\u8fbe\u4f53\u7cfb\uff09\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\"<\/p>\n

\u56fe3.\u7533\u62a5\u6750\u6599\u4e2d\u7684\u5404\u5de5\u827a\u53bb\u9664LRV\u5206\u5e03\uff08\u622a\u6b622009\uff09\uff09.\u6bcf\u4e00\u4e2a\u76f4\u65b9\u56fe\u4ee3\u8868\u6bcf\u79cd\u6e05\u9664\u80fd\u529b\u7684\u6848\u4f8b\u6bd4\u4f8b\u3002(a)\u4eb2\u548c\u5c42\u6790, (b) AEX\u6d41\u7a7f\u6a21\u5f0f, (c)CEX\u7ed3\u5408\u6d17\u8131\u6a21\u5f0f,(d) AEX\u7ed3\u5408\u6d17\u8131\u6a21\u5f0f,(e\u2013g)\u4f4epH\u75c5\u6bd2\u706d\u6d3b,(h) \u5927\u5b54\u6ee4\u819c,(i and j)\u5c0f\u5b54\u6ee4\u819c.e: \u75c5\u6bd2\u662f\u5426\u5b8c\u5168\u6e05\u9664\u6bd4\u4f8b(lightgray) \u548c(darkgray) \u75c5\u6bd2\u5b8c\u5168\u6e05\u9664.a\u2013i: \u4f7f\u7528\u7684\u662f\u9006\u8f6c\u5f55\u75c5\u6bd2;(j) \u4f7f\u7528\u7684\u662f\u7ec6\u5c0f\u75c5\u6bd2.<\/span><\/p>\n

\"\u751f\u7269\u5236\u54c1\uff08\u6765\u6e90CHO\u8868\u8fbe\u4f53\u7cfb\uff09\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\"<\/p>\n

\u56fe4.\u6270\u4e71\u9759\u7535\u4f5c\u7528\u5bf9\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u7684\u5f71\u54cd\u3002\uff08a\uff09QSFF Resin at 25 mM NaCl\u548c1M NaCl\uff0cSFFbase resin\uff08\u4e0d\u542b\u57fa\u56e2\uff09at25 mM NaCl.(b)\u4f7f\u7528\u4e00\u79cdmab1\u4f5c\u4e3a\u539f\u6599\uff0cQSFF\u4f5c\u4e3a\u586b\u6599\uff0c\u75c5\u6bd2\u6d88\u9664\u80fd\u529b\u968f\u7535\u5bfc\u7387\u7684\u53d8\u5316\u8d8b\u52bf\u3002\uff08c\uff09QSFF\u548cSFFbase resin\uff08\u4e0d\u542b\u57fa\u56e2\uff09\u5728\u7535\u5bfc\u73877mS\/cm\u65f6\u7684\u75c5\u6bd2\u6e05\u9664\u80fd\u529b\u3002<\/span><\/p>\n


<\/p>\n

\"\u751f\u7269\u5236\u54c1\uff08\u6765\u6e90CHO\u8868\u8fbe\u4f53\u7cfb\uff09\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\"<\/p>\n

\u56fe5.pH\u548c\u7535\u5bfc\u7387\u5bf9AEX\uff08\u7ed3\u5408\u6d17\u8131\u6a21\u5f0f\uff09\u548cCEX\uff08\u7ed3\u5408\u6d17\u8131\u6a21\u5f0f\uff09\u6d88\u9664\u75c5\u6bd2\u7684\u5f71\u54cd\u3002a:CEX load\u548celutionpH\u5bf9\u75c5\u6bd2\u6d88\u9664\u7684\u5f71\u54cd.b: CEX load\u548c\u6d17\u8131\u76d0\u6d53\u5ea6\u76d0\u6d53\u5ea6\u5bf9\u75c5\u6bd2\u6d88\u9664\u7684\u5f71\u54cd.c: AEX load\u548celutionpH\u5bf9\u75c5\u6bd2\u6d88\u9664\u7684\u5f71\u54cd.AEX load\u548c\u6d17\u8131\u76d0\u6d53\u5ea6\u76d0\u6d53\u5ea6\u5bf9\u75c5\u6bd2\u6d88\u9664\u7684\u5f71\u54cd<\/span><\/p>\n

\u53c2\u8003\u6587\u732e\uff1a<\/span><\/strong><\/h1>\n

1. Curtis S, Lee K, Blank GS, Brorson K, Xu Y.2003. Generic\/matrixevaluation of SV 40 clearance by anion exchange chromatography inflow-through mode. Biotechnol Bioeng 84(2):179-186<\/span><\/p>\n

2. G.R. Miesegaes, S.C.Lute, E.K.Read, and K.A. Boroson. 2013.ViralClearance by flow-through Mode Ion Exchange Columns and MembraneAdsorbers. American Institute of Chemical Engineers 30(1):124-131<\/span><\/p>\n

3. Scott Lute, Lenore Norling, Michael Hanson et al.2008. Robustnessof virus removal by protein A chromatography is independent of medialifetime. Journal of Chromatography A,1205:17-25<\/span><\/p>\n

4. Lisa Connell-Crowley, Elizabeth A. Larimore, Ron Gillespie. 2013.Using high throughput screening to define virus clearance bychromatography resins. Biotechnology Bioengineering 110(7):1984-1994<\/span><\/p>\n

5. Kathryn Martin Remington, Robert Kelly, John Zehmer.2015. Viralclearance by protein A, anion exchange and cation exchangechromatography steps. American Pharmaceutical Review.<\/span><\/p>\n

6. Min Zhang, George R. Miesegaes, Michael Lee et al. 2014. Qualityby design approach for viral clearance by protein A chromatography.Biotechnology Bioengineering 111(1):95-103<\/span><\/p>\n

7. George Miesegaes, Scott Lute, Kurt Brorson. 2010. Analysis ofviral clearance unit operations for monoclonal antibodies.Biotechnology Bioengineering 106(2):238-246<\/span><\/p>\n

8. Daniel M. Strauss, Scott Lute, Zinaida Tebaykina et al. 2009.Understanding the mechanism of virus removal by Q sepharose fast flowchromatography during the purification of CHO- derivedbiotherapeutics. Biotechnology Bioengineering 104(2):371-380<\/span><\/p>\n

9. Abhinav A Shukla, Hazel Aranha.2015. Viral clearance forbiopharmaceutical downstream processes. Pharmaceutical Bioprocessing3(2): 127-138<\/span><\/p>\n

Glen Bolton, Johannes Blumel.2016. Conference summary: Key discussionand outcomes, pending questions and proposed experiments. PDA J PharmSci and Tech 70\uff1a477-481<\/span><\/p>\n

10. Jun zhi Wang et al. 3rd Version. Research, developmentand quality control of biopharmaceuticals.<\/span><\/p>\n

11. ICH Q5A(R1): Viral safety evaluation of biotechnology productsderived from cell lines of human or animal origin.<\/span><\/p>\n

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